Ostomy appliance coupling system with a coupling part having an enclosed volume of air

ABSTRACT

An ostomy appliance coupling system includes a first coupling part with a gas-impermeable layer forming an enclosed volume of air, with the gas-impermeable layer sealed to one of a sealing wafer and an ostomy bag. A second coupling part is connected to an opposite one of the sealing wafer and the ostomy bag. A depression in the second coupling part is shaped to receive and couple with a protruding member of the first coupling part to removably couple the ostomy bag to the sealing wafer.

BRIEF SUMMARY

Embodiments provide a coupling system for an ostomy appliance comprisinga sealing wafer and a collecting bag. The coupling system comprises afirst coupling part and a second coupling part. The first and secondcoupling parts each encircle a stoma-receiving opening. The first andsecond coupling parts are configured to connect the sealing wafer to thecollecting bag. The first coupling part comprises a first base portion,a second base portion and a connecting portion extending between thefirst and second base portions. The first base portion is arrangedradially closer to the stoma-receiving opening than the second baseportion. The first coupling part comprises an enclosed volume of air.The enclosed volume of air is at least partially enclosed by the firstbase portion, the second base portion and the connecting portion.

BACKGROUND

In connection with surgery for a number of diseases in thegastro-intestinal tract, one of the consequences in many cases is thatthe user is left with an abdominal stoma, such as a colostomy or anileostomy in the abdominal wall for the discharge of visceral content.The discharge of visceral content, including intestinal gases, cannot beregulated at will. For that purpose, the user will have to rely on anostomy appliance to collect the material emerging from such opening, ina bag later emptied and/or discarded at a suitable time.

In many cases, the user will attach a base plate or sealing wafer to thesurface of the skin surrounding the opening. This base plate then mayserve as an attachment anchor for an ostomy bag that attaches to thebase plate. The attachment between the base plate and the ostomy bagserves at least to bear the load of the ostomy bag and to form a sealbetween the base plate and the ostomy bag. These two purposes putdifferent constraints on the attachment.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other.

Like reference numerals designate corresponding similar parts.

FIG. 1 illustrates a schematic cross-sectional side view of anembodiment of an ostomy appliance.

FIG. 2 illustrates a schematic of an enlarged cross-sectional view ofembodiment of an ostomy appliance.

FIG. 3 illustrates an embodiment of an ostomy appliance.

FIG. 4 illustrates a schematic cross-sectional side view of anembodiment of an ostomy appliance.

FIG. 5 illustrates a schematic cross-sectional side view of anembodiment of an ostomy appliance.

FIG. 6 illustrates a schematic cross-sectional side view of anembodiment of an ostomy appliance.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

Embodiments provide an ostomy appliance having improved sealingproperties to prevent leakage. Embodiments provide an ostomy applianceconfigured with separated sealing and load bearing capabilities.

Accordingly, in a first aspect, embodiments provide a coupling systemfor an ostomy appliance comprising a sealing wafer and a collecting bag,the coupling system comprising a first coupling part and a secondcoupling part, the first and second coupling parts each encircling astoma-receiving opening, the first and second coupling parts beingconfigured to connect the sealing wafer to the collecting bag, whereinthe first coupling part comprises a first base portion, a second baseportion and a connecting portion extending between the first and secondbase portions, the first base portion being arranged radially closer tothe stoma-receiving opening than the second base portion, and whereinthe first coupling part comprises an enclosed volume of air, theenclosed volume of air being at least partially enclosed by the firstbase portion, the second base portion and the connecting portion.

The first coupling part and the second coupling part are configured toconnect the collecting bag to the sealing wafer. During normal use, thesealing wafer is attached to the skin of the user and the collecting bagis connected to the sealing wafer. The first and second coupling partsmay be arranged so that the first coupling part forms part of thesealing wafer and the second coupling part forms part of the collectingbag, or so that the first coupling part forms part of the collecting bagand the second coupling part forms part of the sealing wafer, in bothcases, visceral content from a user may be received by the ostomyappliance through the stoma-receiving openings of the first and secondcoupling parts.

The volume of air at least partially enclosed by the first coupling partallows the first coupling part to have a mechanical flexibility. Themechanical flexibility can be achieved by appropriate choice of materialand material thickness for the first coupling part. In the presentcontext, the term mechanical flexibility is to be understood as amechanical flexibility of the structure being large enough to allow anaverage person to deform and/or bend the structure with the fingers.Accordingly, the enclosed volume of air may allow the first couplingpart to deform in order to provide additional flexibility in relation tothe second coupling part and/or the user's body. For instance, the shapeof the user's body often changes when the user moves the body duringeveryday activities such as bending over, standing up, twisting thebody, jumping, etc. The ability of the first coupling part to conform tosuch movements provides improved sealing between the ostomy applianceand the user's skin.

In embodiments, the first and second coupling parts are configured to begas and liquid impermeable so as to form a gas and liquid impermeableseal when connected.

The sealing wafer is provided with a proximal surface configured forattachment to the user's skin. In embodiments, the proximal surface ofthe sealing wafer comprises an adhesive for attachment to the skin. Inembodiments, the adhesive is a pressure sensitive adhesive. Inembodiments, the first coupling part or the second coupling part isarranged on a distal surface of the sealing wafer.

FIG. 1 illustrates a schematic cross-sectional side view of anembodiment of an ostomy appliance 1 with a coupling system 3 accordingto a first aspect. The coupling system 3 is configured to connect thesealing wafer 5 to the collecting bag 7 and includes a first couplingpart 9 and a second coupling part 11. The first coupling part 9 includesan enclosed volume of aft 10.

The sealing wafer 5 defines a proximal surface 13 provided with anadhesive adapted for engagement to a skin surface 15 of a user andtherefore presents skin-friendly characteristics. In one embodiment, theadhesive is an adhesive including polyisobutylene,styrene-isoprene-styrene and hydrocolloids such as, but not limited to,the types of adhesives disclosed in WO 99/11302. In embodiments, thesealing wafer 5 defines a first stoma-receiving opening 17, Inembodiments, the first stoma-receiving opening 17 of the sealing wafer 5coincides with a second stoma-receiving opening 18 of the first couplingpart 9. In one embodiment, the sealing wafer 5 is adapted to allow thefirst stoma-receiving opening 17 to be customized to a size and shape ofa user's individual stoma 19.

The collecting bag 7 includes a proximal wall 21 and a distal wall 23.The walls 21, 23 are joined along their individual outer peripheries toform a collecting volume inside the collecting bag 7 for stomal output.The walls 21, 23 are made of and liquid impermeable foil-material (forexample of polyethylene (PE), polyvinyl-chloride (PVC) orethylene-vinyl-acetate (EVA)) that is welded around the edges of the rimso as to form a pouch defining a waste collection chamber. In someembodiments, the collecting bag 7 includes a foldable outlet (not shown)at a lower portion of the collecting bag 7 for intermittent emptying ofstomal output from the collecting bag 7. The collecting bag 7 includes awaste inlet opening 25 in the proximal wall 21 of the collecting bag 7for receiving stomal output. The waste inlet opening 25 coincides with athird stoma-receiving opening 27 of the second coupling part 11.

The first and second coupling parts 9, 11 of the embodiment illustratedin FIG. 1 are configured to detachably connect. In present context,detachably connect means that the first coupling part 9 and the secondcoupling part 11 can be connected and separated from each other withoutbreaking the coupling system 3. In embodiments, the first and secondcoupling parts 9, 11 include resilient coupling members configured toform a mating couple. In embodiments, the resilient coupling membershave complementary shapes that need to deform for the coupling membersto change from being connected to disconnected and vice versa. In otherembodiments, the first and second coupling parts 9, 11 are configured tofixedly connect. In present context, fixedly connect means that thefirst and second coupling parts 9, 11 cannot be separated from eachother without breaking the coupling system 3 and rendering it useless.

FIG. 2 illustrates a schematic of an enlarged cross-sectional view ofone embodiment including first and second coupling parts 9, 11. Thefirst coupling part 9 includes a first base portion 33, a second baseportion 35 and a connecting portion 37. In embodiments, the first baseportion 33 is arranged radially closer to the first stoma-receivingopening 17 (not shown) than the second base portion 35. The first baseportion 33, second base portion 35 and connecting portion 37 partiallyenclose a volume of air 10. The dashed line 40 indicates a furtherperimeter of the enclosed volume of air 10. In embodiments, the furtherperimeter 40 forms part of the first coupling part 9. In embodiments,the further perimeter 40 is defined by a surface of the sealing wafer 5or the collecting bag 7.

FIG. 3 is a schematic, perspective view of a first coupling part 9according to one embodiment. In FIG. 3 , the second stoma-receivingopening 18 of the first coupling part 9 is arranged radially inward of aperimeter 49 defined by the first base portion 33.

FIG. 4 illustrates a schematic cross-sectional side view of oneembodiment of an ostomy appliance 1 with a coupling system 3, In theembodiment of FIG. 4 , the coupling system 3 does not include resilientcoupling members forming a mating couple. In the embodiment of FIG. 4 ,the first and second coupling parts 9, 11 are configured to connect byuse of an adhesive. More specifically, an adhesive on a proximal surfaceof the second coupling part 11 is adapted to adhere to a distal side ofthe first coupling part 9. The adhesive allows the first and secondcoupling parts 9, 11 to detachably connect or fixedly connect.

In embodiments, a mechanical flexibility of the first coupling partallows the enclosed volume of air 10 to be compressed and/or deformed inresponse to an external pressure applied to the first coupling part.

Thereby, the enclosed volume of air 10 may be directly influenced by theexternal pressure applied to the first coupling part. Accordingly, themechanical properties of the first coupling part are, at least in part,determined by the mechanical properties of the enclosed volume of air10. This further enhances the ability of the first coupling part toconform to alternating shapes and avoid leakage.

In present context, the ‘external pressure applied’ is meant as thepressure applied by, e.g. the fingers of an average person. Accordingly,the mechanical flexibility of the first coupling part allows theenclosed volume of air 10 to be compressed and/or deformed in responseto an external pressure applied by the fingers of an average person.

Appropriate materials for achieving the mechanical flexibility of thefirst coupling part comprise polymers. In one embodiment, an appropriatematerial comprises silicone. In one embodiment, it comprises siliconerubber. In one embodiment, the first coupling part comprises a heatcured elastomer. Other types of polymers are also appropriate. In oneembodiment, the first coupling part has a Shore hardness in the range of35A to 85A, more particularly 40A to 70A, more particularly 45A to 65A.By ‘Shore hardness’ is meant a hardness measured according to the ASTMD2240 standard with a type A durometer on the A scale. The thickness ofthe material may be chosen based on the flexibility of the material.Accordingly, a more flexible material may have a larger thickness than aless flexible material while still preserving a similar mechanicalflexibility of the first coupling part, which allows the enclosed volumeof air 10 to be compressed and/or deformed in response to an externalpressure in the sense of the present context. Moreover, if in a firstembodiment, the first coupling part is made from a material having afirst Shore hardness and a first thickness, and in a second embodiment,the first coupling part is made from a material having a second Shorehardness and a second thickness, a similar mechanical flexibility of thetwo first coupling parts may be achieved even if the first Shorehardness is smaller than the second Shore hardness, if the firstthickness is larger than the second thickness. In embodiments, theseoptions provide for differentiating the firmness of the coupling parts,which in turn allows for adapting the attachment (and detachment) forcesof the coupled parts to suit the physical capabilities of differentusers.

In embodiments, the enclosed volume of air 10 exerts an internalpressure on at least part of the first coupling part, and the internalpressure is configured to support at least part of the first couplingpart when the first and second coupling parts are connected.

Thereby, the enclosed volume of air 10 contributes to the mechanicalresilience of the first coupling part. Moreover, as the enclosed volumeof air 10 is compressed, the shape of the first coupling part willdepart from its initial shape. The compression causes the internalpressure of the enclosed volume of air 10 to increase, which works torestore the initial shape of the first coupling part. In embodiments,the enclosed volume of air 10 provides the first coupling part with anenhanced flexibility to make it bend and conform to the body of the usermore easily. It also provides the first coupling part with sufficientmechanical resilience to minimize deformation in the use situation. Bothof these effects, on their own and in combination, provide an improvedsealing between the connected first and second coupling parts.

In the embodiment illustrated in FIG. 2 , the first base portion 33,second base portion 35 and connecting portion 37 are made of arelatively flexible material having a Shore hardness in the range of 35Ato 85A, which allows the enclosed volume of air 10 to be compressed anddeformed in response to an external pressure applied to the firstcoupling part 9. A mechanical flexibility of the first coupling part 9allows it to deform and adjust in response to movements of the user. Theenclosed volume of air 10 will exert an internal pressure on the firstbase portion 33, second base portion 35 and connecting portion 37. Theinternal pressure supports at least these portions 33, 35, 37 when thefirst and second coupling parts 9, 11 are connected. Suitable materialsfor the first coupling part could be any type of polymer or othermaterial that may produce mechanically flexible and gas-impermeablemembers. In the embodiment of FIG. 2 , the first and second couplingparts 9, 11 are made from a heat cured elastomer having a Shore hardnessof 65A made from silicone rubber.

In embodiments, the first coupling part comprises a first attachmentportion and the second coupling part comprises a second attachmentportion, wherein the first and second attachment portions combine toform a first attachment defining a first detachment force between thefirst and second coupling parts when the first and second coupling partsare connected.

Thereby, the attachment portions of the first and second coupling partsprovide a detachment force. In one embodiment, the attachment portionsare configured to provide a detachment force sufficient to carry theload of the collecting bag. In one embodiment, the detachment force islower than what is required to carry the load of the collecting bag. Inembodiments, the attachment portion of the first coupling part and/orthe second coupling part are structurally different from the first andsecond base portions and/or the connecting portion, so as to have adifferent mechanical flexibility, different thickness, etc.

In the embodiment illustrated in FIG. 2 , the first coupling part 9includes a first attachment portion 41 in the form of a resilientcoupling member including a protrusion 43, The second coupling part 11includes a second attachment portion 45 in the form of a resilientcoupling member including a depression 47 formed in the resilientcoupling member. In embodiments, the shapes of the first and secondattachment portions 41, 45 are configured to deform in order for theattachment portions 41, 45 to connect and/or to disconnect. Accordingly,a resilience towards deformation of the attachment portions 41, 45provides a first detachment force.

In embodiments, the first attachment portion and/or the secondattachment portion are less mechanically flexible than the first andsecond base portions. Thereby, the less mechanically flexible firstand/or second attachment portions provide a larger detachment forcebecause they are more resilient towards deformations.

In embodiments, the second attachment portion comprises a resilientcoupling member. In one embodiment, the resilient coupling membercomprises a depression. In one embodiment, the first attachment portioncomprises a protrusion. In one embodiment, the protrusion is configuredto fit into the depression of the resilient coupling member to provide afirst detachment force when fitted into the depression.

In embodiments, the depression and protrusion each constitute a matingpart configured to form a mating connection. This improves theattachment between the attachment portions and the sealing properties ofthe connected first and second coupling parts. During a change frombeing disconnected to being connected the first attachment portionand/or the second attachment portion deform to allow the protrusion toenter the depression. Thereby, a first detachment force is provided by aresilience of the first and second attachment portions towardsdeformations. The detachment force may then depend on a hardness of thefirst and second attachment portions.

In embodiments, the first coupling part is arranged on the sealingwafer. The sealing wafer is attached to the skin of the user duringnormal use. The enclosed volume of air in the first coupling partprovides the first coupling part with a larger mechanical flexibilitythan the second coupling part. In order to improve the ability of thesealing wafer to conform to the shape of the skin, it is advantageous toprovide the sealing wafer with the first coupling part and thecollecting bag with the second coupling part. This in turn improves thesealing properties of the coupling system.

In embodiments, the enclosed volume of air 10 is at least partiallyenclosed by a surface of the sealing wafer. This further improves themechanical flexibility of the sealing wafer and thus the ability of thesealing wafer to conform to the shape of the skin. This provides a moreeffective seal between the skin and sealing wafer.

In embodiments, the enclosed volume of air 10 is at least partiallyenclosed by a surface of the collecting bag. This further improves themechanical flexibility of the first coupling part and the sealingproperties of the connected first and second coupling parts.

According to embodiments, the coupling system further comprises a thirdcoupling part and a fourth coupling part, the third and fourth couplingparts being configured to connect and to form a load bearing structuredefining a load bearing detachment force when connected. In embodiments,the first coupling part and second coupling part form a sealingstructure defining a sealing detachment force when connected. Inembodiments, the load bearing detachment force is greater than thesealing detachment force.

Thereby, the first and second coupling parts are relieved from carryingany significant load as the load (caused by the weight of stomal outputin the collecting bag) is substantially carried by the third and fourthcoupling parts. In one embodiment, the third and fourth coupling partsare configured to carry at least 70 percent of the load, moreparticularly at least 80 percent of the load, more particularly at least90 percent of the load, more particularly at least 95 percent of theload. This enables the first and second coupling parts to be designedand configured with little or no regard to their load bearingcapabilities. This provides a solution in which the sealing propertiesof the first and second coupling parts can be optimized for sealing, asthe first and second coupling parts do not need to carry any significantload. This allows for the first and second coupling parts to havegreater mechanical flexibility to efficiently allow the coupling partsto form a seal and conform to movements of the user. Accordingly, byproviding a system with two pairs of coupling parts with each theirdesignated role, i.e. the first and the second coupling parts providinggood sealing properties and the third and fourth coupling partsproviding good load bearing properties, both the sealing properties andthe load bearing properties of the coupling system are improved.

In the embodiment of FIG. 1 , the coupling system further includes athird coupling part 29 and a fourth coupling part 31. The third andfourth coupling parts 29, 31 are configured to form a load bearingstructure defining a load bearing detachment force when connected. Inalternative embodiments, the coupling system 3 does not include thethird and fourth coupling parts 29, 31, in which case the first andsecond coupling parts 9, 11 may be configured to carry the load of thecollecting bag.

In the embodiment of FIG. 1 , the first and second coupling parts 9, 11form a sealing structure defining a sealing detachment force. Inembodiments, the load bearing detachment force of the load bearingstructure is greater than the sealing detachment force of the first andsecond coupling parts. In one embodiment, the second coupling part 11 isattached to the collecting bag via a foldable connection 50. Thereby,the second coupling part 11 can be said to floatingly connect thecollecting bag 7 to the sealing wafer 5. By ‘floatingly connect’ ismeant that the collecting bag 7 is connected to the sealing wafer 5 suchthat movement of the collecting bag 7 relative to the sealing wafer 5,does not cause an immediate, relative movement of the proximal wall 21of the collecting bag 7. In other words, the foldable connection 50allows movement of the collecting bag 7 relative to the sealing wafer 5as long as the foldable connection 50 is not fully extended.

In embodiments, the third and fourth coupling parts 27, 31 of the loadbearing structure are configured to allow less relative movement of thecollecting bag 7 and sealing wafer 5, than the first and second couplingparts 9, 11. Accordingly, the load bearing structure will experiencestrain before the sealing structure. Thus, the sealing structure may berelieved from load bearing. In the embodiment of FIG. 1 , the fourthcoupling part 31 is attached to the collecting bag 7 and includes anadhesive on a proximal side. The adhesive on the fourth coupling part 31attaches to the sealing wafer 5. In this case, the third coupling part29 forms part of the sealing wafer 5. In embodiments, the third andfourth coupling parts 29, 31 are arranged radially outward of the firstand second coupling parts 9, 11 in relation to the stoma-receivingopenings 18, 27.

FIG. 5 illustrates a schematic cross-sectional side view of anembodiment of an ostomy appliance 1 with a coupling system 3. In theembodiment illustrated in FIG. 5 , the third and fourth coupling parts29, 31 form a load bearing structure defining a load bearing detachmentforce. In FIG. 5 , the third and fourth coupling parts 29, 31 areillustrated to include resilient coupling members 51, 53. In oneembodiment, the resilient coupling members 51, 53 are configured todeform in order for the first and second coupling parts 29, 31 toconnect and to disconnect. In embodiments, the third and fourth couplingparts 29, 31 are significantly easier to connect than to disconnect. Inembodiments, a hardness of the resilient coupling members 51, 53 issignificantly larger than a hardness of the first and second couplingparts 9, 11 forming a sealing structure defining a sealing detachmentforce. Accordingly, in embodiments the load bearing detachment force issignificantly larger than the sealing detachment force. In embodiments,the third and fourth coupling members 29, 31 are configured todetachably connect or fixedly connect. In embodiments that include theshapes illustrated in FIG. 5 , the detachment force may be varied byvarying the hardness of the resilient coupling members 51, 53.

In embodiments, the first coupling part is arranged radially closer tothe stoma-receiving opening than the third coupling part. Inembodiments, the second coupling part is arranged radially closer to thestoma-receiving opening than the fourth coupling part. Thereby, asealing structure formed by the first and second coupling parts locatesbetween the stoma-receiving openings and the load bearing structureformed by the third and fourth coupling parts. Accordingly, the sealingstructure prevents visceral content from reaching the load bearingstructure. In embodiments, the materials of the load bearing structureare allowed to be less resistant towards visceral content than materialsof the sealing structure.

In embodiments, the third and fourth coupling parts are configured todetachably connect. This is particularly advantageous if the first andsecond coupling parts are also configured to detachably connect. Theuser may then leave the sealing wafer on while changing the collectingbag.

In embodiments, the third and fourth coupling parts are configured tofixedly connect. In embodiments, this enables the load bearing structureformed by the third and fourth coupling parts to define a larger loadbearing detachment force, as disconnection capability is not needed.

In embodiments, the first coupling part and the third coupling part areseparate parts, and/or the second coupling part and the fourth couplingpart are separate parts. In embodiments, ‘separate parts’ should beunderstood to mean that the parts are provided at a distance from eachother without being in direct physical contact, albeit beinginterconnected.

In embodiments, the first and third coupling parts are arranged oneither the collecting bag or the sealing wafer, i.e. the first and thirdcoupling parts are arranged on the collecting bag or the first and thirdcoupling parts are arranged on the sealing wafer. In embodiments,wherein the first and third coupling parts are arranged on thecollecting bag, the second and fourth coupling parts are arranged on theone of the sealing wafer and vice versa. In embodiment, the first andthird coupling parts are designed and arranged independent of the secondand fourth coupling parts. This provides a coupling system havingimproved sealing and load bearing properties.

In another aspect, embodiments provide a coupling system for an ostomyappliance comprising a collecting bag, the coupling system comprising:

-   -   a sealing coupling part encircling a stoma-receiving opening,        and comprising a proximal surface for facing a user's skin and a        distal surface for facing away from the user;    -   a load-bearing coupling part encircling a stoma-receiving        opening, and comprising a proximal surface for facing the distal        surface of the sealing coupling part and a distal surface for        facing the collecting bag, wherein the load-bearing coupling        part comprises an extension for connecting to the user's body        radially offset from the sealing coupling part; and    -   a connecting structure for interconnecting the sealing coupling        part and the load-bearing coupling part.

In embodiments, the sealing coupling part is configured to attach to theuser's skin via the proximal surface of the sealing coupling part. Inembodiments, the proximal surface of the sealing coupling part comprisesan adhesive or a sealing mating part. In embodiments, the load-bearingcoupling part is arranged on the collecting bag. In embodiments, theextension for connecting to the user's body is connected directly to theuser's body by an adhesive on the extension. In embodiments, theextension connects to the user's body via the distal surface of a wafer,the wafer at least partly surrounding the sealing coupling part. Inembodiments, the extension connects to the wafer by an adhesive on thewafer and/or the extension. In embodiments, the extension connects tothe wafer via mating parts on either surface configured to form amechanical mating connection, One suitable mechanical mating connectioncould e.g. be in the form of Velcro.

In embodiments, the sealing coupling part comprises an enclosed volumeof air.

In embodiments, the connecting structure is arranged on the proximalsurface of the load bearing coupling part. In embodiments, an adhesiveor a mating part forms a mechanical mating connection with a sealingmating part of the sealing coupling part.

By connecting the extension of the load-bearing coupling part to theuser's skin, or a wafer on the user's skin, without connecting it to thesealing coupling part, the sealing coupling part may be relieved fromcarrying any significant load as this load is carried by load-bearingcoupling part. This enables the sealing coupling part to be designed andconfigured with little or no constraints in terms of load bearingcapabilities. This provides improved sealing properties, as the sealingcoupling part does not need to carry any significant load.

FIG. 6 illustrates a schematic cross-sectional side view of anembodiment of an ostomy appliance 101 with a coupling system 103 forattaching a collecting bag 107 to a user. In embodiments, the couplingsystem 103 comprises a sealing coupling part 109, a load bearingcoupling part 111 and a connecting structure 112.

In embodiments, the sealing coupling part 109 defines a proximal surface113 provided with an adhesive adapted for engagement to a skin surface115 of a user and therefore presents with skin-friendly characteristics.The sealing coupling part 109 defines a stoma-receiving opening 117. Inone embodiment, the sealing coupling part 109 is adapted to allow thestoma-receiving opening 117 to be customized to a size and shape of auser's individual stoma 119.

The collecting bag 107 includes a proximal wall 121 and a distal wall123, The collecting bag 107 includes an inlet opening 125 in theproximal wall 121 of the collecting bag 107 for receiving stomal output.The inlet opening 125 coincides with a stoma-receiving opening 127 ofthe load bearing coupling part 111.

In embodiments, the load-bearing coupling part 111 includes an extension133 for connecting to the user's body in an area marked by the dashedlines 135 radially offset from the sealing coupling part 109, Inembodiments, the extension 133 connects directly to the skin 115 of theuser's body by way of an adhesive on a proximal surface 137 of theextension 133.

In embodiments, the connecting structure 112 includes a first attachmentportion 141 in the form of a resilient coupling member including aprotrusion 143, and a second attachment portion 145 in the form of aresilient coupling member including a depression 147 formed in theresilient coupling member. In embodiments, the first and secondattachment portions 141, 145 are configured to deform in order for theattachment portions to connect and disconnect. Accordingly, a resiliencetowards deformation of the attachment portions 141, 145 can be said toprovide a sealing detachment force. In embodiments, the connectingstructure includes a foldable extension 150, which in one embodimentallows some movement of the sealing coupling part 109 relative to theload bearing coupling part 111.

The invention claimed is:
 1. An ostomy appliance coupling systemcomprising: a sealing wafer having a proximal surface adapted to attachto skin, a distal surface opposite of the proximal surface, and astoma-receiving opening formed through a thickness of the sealing wafer;an ostomy bag having a proximal wall, an opposite distal wall, and awaste inlet opening formed in the proximal wall of the ostomy bag; afirst coupling part comprising a gas-impermeable layer forming anenclosed volume of air, with the gas-impermeable layer sealed to one ofthe distal surface of the sealing wafer and the proximal surface of theostomy bag to prevent escape of the enclosed volume of air from theostomy appliance, and the first coupling part comprising a protrudingmember; and a second coupling part connected to an opposite one of thedistal surface of the sealing wafer and the proximal surface of theostomy bag, with the second coupling part comprising a depressionadapted to receive and couple with the protruding member of the firstcoupling part to removably couple the ostomy bag to the sealing wafer.2. The ostomy appliance coupling system of claim 1, wherein the firstcoupling part encircles the stoma-receiving opening of the sealing waferand the second coupling part encircles the waste inlet opening of theostomy bag.
 3. The ostomy appliance coupling system of claim 1, whereinthe first coupling part comprises: a first base portion sealed to one ofthe distal surface of the sealing wafer and the proximal surface of theostomy bag; a second base portion sealed to another of the distalsurface of the sealing wafer and the proximal surface of the ostomy bag;and wherein the gas-impermeable layer is connected between the firstbase portion and the second base portion to form the enclosed volume ofair sealed relative to one of the distal surface of the sealing waferand the proximal surface of the ostomy bag.
 4. The ostomy appliancecoupling system of claim 3, wherein the first base portion is radiallycloser to a respective one of the stoma-receiving opening and the wasteinlet opening than is the second base portion.
 5. The ostomy appliancecoupling system of claim 1, wherein the first coupling part and thesecond coupling part form a gas impermeable seal and a liquidimpermeable seal when coupled.
 6. The ostomy appliance coupling systemof claim 1, wherein the proximal surface of the sealing wafer comprisesan adhesive selected from the group consisting of polyisobutylene,styrene-isoprene-styrene, and adhesive including a hydrocolloid.
 7. Theostomy appliance coupling system of claim 1, further comprising a firstadhesive applied to the distal surface of the sealing wafer and a secondadhesive applied to the proximal surface of the ostomy bag; wherein thefirst adhesive and the second adhesive are configured to allow the firstcoupling part to detachably connect with the second coupling part. 8.The ostomy appliance coupling system of claim 1, wherein the protrudingmember of the first coupling part is less mechanically flexible than thegas-impermeable layer forming the enclosed volume of air.
 9. The ostomyappliance coupling system of claim 1, wherein the second coupling partcomprising the depression is less mechanically flexible than thegas-impermeable layer forming the enclosed volume of air.
 10. An ostomyappliance coupling system comprising: a sealing wafer having an adhesiveproximal surface adapted to attach to skin, a distal surface opposite ofthe adhesive proximal surface, and a stoma-receiving opening formedthrough a thickness of the sealing wafer; an ostomy bag having aproximal wall, an opposite distal wall, and a waste inlet opening formedin the proximal wall of the ostomy bag; a first coupling part comprisinga gas-impermeable layer forming an enclosed volume of air, with thegas-impermeable layer sealed to the distal surface of the sealing waferto prevent escape of the enclosed volume of air from the ostomyappliance, and the first coupling part comprising a protruding member;and a second coupling part connected to the proximal surface of theostomy bag, with the second coupling part comprising a depressionadapted to receive and couple with the protruding member of the firstcoupling part to removably couple the ostomy bag to the sealing wafer.